The relative positioning and pressure exerted by and between anatomical masses, structures, implants, and the like are often times crucial in assessing a patient's condition and making a proper diagnosis. In this regard, it is often of particular interest to determine the degree of pressure being exerted upon or by a particular type of anatomical structure, as well as whether or not the positioning of one or more structures is maintained in a proper orientation. For example, it is often ideal to measure the pressure capable of being exerted by either the urethral or anal sphincter, to thus assess sphincter tone, in making a diagnosis of urinary or fecal incontinence. It is likewise often desirable to measure a patient's urethral pressure profile to thus measure urethral resistance to outflow of urine or to measure abdominal or bladder leak point pressure. Further areas where such need arises include the monitoring of intercranial pressure for patients with hydro-encephalitis or head injuries, intramuscular compartment pressure for patients with compartment syndrome, intraesophageal pressure for patients being evaluated for gastroesophageal reflux disease (GERD), and intravascular pressure to assess blood pressure. Still further examples include needs that often arise with respect to intracavitary uses such as bladder, intra-pleural and intra-abdominal pressure.
In addition to the frequent need to measure the pressure and/or spatial relationship in or between anatomical masses/structures, implants, and the like, is the need to measure and determine physiological pressures and relative spacing between anatomical masses/structures during specific types of surgical procedures, and in particular surgical procedures incorporating the use of slings, grafts, and the like for supporting and separating anatomical structures and tissue masses. Such procedures are well known in the art and include, among numerous others, pubovaginal sling surgery, the specific aspects of which are set forth in Applicant's issued U.S. Pat. No. 6,050,937, issued on Apr. 18, 2000 entitled SURGICAL TENSION/PRESSURE MONITOR and U.S. Pat. No. 6,302,840, issued on Oct. 16, 2001 entitled SURGICAL MONITOR, the teachings of which are expressly incorporated herein by reference. Additionally exemplary of such procedures include fundoplication, a procedure well known in the art for mobilizing the lower end of the esophagus and plication of the fundus of the stomach around it (i.e., fundic wrapping) in the treatment of reflux esophagitis that may be associated with various disorders, such as hiatal hernia.
In both such procedures, it is necessary to maintain proper support and orientation of a particular anatomical structure. In the case of pubovaginal sling surgery, optimal positioning of the sling relative the urethra, as well as the degree of tension imparted by the sling to the urethra, must be achieved in order to attain a favorable patient outcome. Likewise, in the case of fundoplication, optimal positioning of the fundus relative the esophagus must be made in order to obtain a successful outcome.
The foregoing examples are merely two of a wide variety of procedures performed that place great demands on the surgeon to not only securely attach a given tissue, sling, graft and the like into position, but to also position the same so that it offers the desired/selective support. The latter aspect is particularly difficult insofar as there is generally lacking in the art any type of mechanism by which a surgeon can know with certainty when a given tissue, sling or graft is optimally positioned and/or imparts the necessary support. Indeed, most surgeons only acquire such skill through substantial experience and that new, inexperienced surgeons typically produce substantially less favorable outcomes due to their inability to know when or how to affix an implant, tissue, sling or graft such that the same is optimally positioned.
In an attempt to address such shortcomings, at least one product, namely, the T-DOC air-charged catheters produced by T-Doc Company. of Mt. Laurel, N.J., has been developed to provide pressure-sensing measurements. Essentially, such device comprises a catheter-deployed balloon requiring an injection of air which thus produces an “air-charge” baseline of pressure. Once properly positioned for the applicable procedure (i.e., urodynamic procedures), changes in the physiologic pressure that occur at a particular site are transmitted through a micro-volume of trapped air in the T-DOC catheter. Another intent for use in applications involving the diagnosis of laryngopharyngeal reflux has been the Medtronic response catheter system that measures reflux at the lower esophageal level at the level of the esophageal inlet. Such system is operative to span the distance about the esophageal inlet.
Such systems, however, are complex and difficult to accurately deploy. Moreover, the T-DOC system requires specialized transducer docking cables and further relies upon sophisticated and expensive componentry that, in certain applications, can produce unreliable results. Also, the T-DOC system in certain applications is difficult and time consuming to deploy. The latter aspect is particularly problematic insofar as to the extent such catheter-based system is unnecessarily prolonged or if a given procedure cannot be scheduled within a requisite amount of time, patient in need of such procedure (i. e., the performance of a urodynamic profile) might be prone to more infections and pain from the possible need for extra catheterization.
Accordingly, there is a substantial need in the art for a system and procedure which provides accurate and reliable data regarding the measurement of physiological pressures that may be exerted within a cavity or tube;, especially in relation to routinely performed procedures such as urodynamic procedures. There is likewise a substantial need in the art for a system and procedure providing accurate and reliable data related to the measurement of physiological stresses and pressures exerted between anatomical masses/tissues and structures, implants, and the like, as well as the relative spatial positioning of one or more anatomical structures to thus enable a physician to properly evaluate a particular condition of a patient. There is likewise a need in the art for such a system and procedure that has widespread application over a variety of physiological pressure/spatial parameters that are useful in assessing a wide variety of medical conditions.
There is likewise a need in the art for such a system and method that are operative to provide a surgeon during the performance of an operation involving the fixation of an implant, tissue, sling or graft into position with an indication as to when such implant, tissue, sling or graft is optimally fixed into position relative an anatomical structure, and that further quantifies the amount of tension or pressure being imparted by the sling or graft to the anatomical structure, and/or may further provide an indication of the relative positioning of the implant, tissue, sling or graft to such structure. There is further lacking in the art a system and method that, in addition to identifying the amount of tension and pressure imparted by a given sling or graft upon an anatomical structure and a relative spatial positioning therebetween, also provides an indication as to the optimal parameters of tension or spatial relationship of the sling relative such anatomical structure. Still further, there is a need for such systems and methods that can be deployed such that a higher number of favorable patient outcomes is attained.